Randomized controlled clinical trial Dotaz Zobrazit nápovědu
Aim: To report a trial protocol to determine if a self-care program enhances quality of life and sense of coherence in community-dwellers aged 65 years or over. Design: A randomized controlled trial with a two-group pretest and posttest will be conducted in a community activity center involving a sample of 64 community-dwellers who are 65 years or over. Methods: The intervention group will receive Resource Enhancement and Activation Program, a structured 12-week self-care program comprising 24 activities based on a salutogenic framework. The control group will receive the routine service. Both outcome and process evaluations will be used. Outcomes will be measured using standardized tools and these include quality of life, sense of coherence, satisfaction with life, activation measure, well-being, depression, loneliness and resilience. Focus group interviews will be conducted to explore participants’ views on the program. Conclusion: This study will provide evidence on the feasibility and effectiveness of a self-care program that is based on a salutogenic framework to promote quality of life and sense of coherence among older community-dwellers.
- MeSH
- denní stacionář pro seniory * metody MeSH
- komunitní ošetřovatelská péče MeSH
- kvalita života * MeSH
- lidé MeSH
- péče o sebe * klasifikace statistika a číselné údaje MeSH
- randomizované kontrolované studie jako téma statistika a číselné údaje MeSH
- senioři MeSH
- Check Tag
- lidé MeSH
- senioři MeSH
- Publikační typ
- práce podpořená grantem MeSH
elektronický časopis
- MeSH
- kardiovaskulární nemoci MeSH
- klinické zkoušky jako téma MeSH
- randomizované kontrolované studie jako téma MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- kardiologie
- NLK Publikační typ
- elektronické časopisy
- MeSH
- antikonvulziva aplikace a dávkování farmakologie terapeutické užití MeSH
- dospělí MeSH
- finanční podpora výzkumu jako téma MeSH
- hodnocení léčiv MeSH
- lidé MeSH
- migréna farmakoterapie patologie prevence a kontrola MeSH
- mladiství MeSH
- svalové křeče patologie MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- randomizované kontrolované studie MeSH
Dietary vitamin K is thought to be an important factor that interferes with anticoagulation stability, but the clinical applicability of this interaction has not been evaluated adequately in prospective studies. METHODS AND RESULTS: In a randomized controlled trial that enrolled outpatients with a recent international normalized ratio (INR) outside the therapeutic target, we compared 2 strategies to optimize long-term oral anticoagulation: (1) a conventional approach based on changes in anticoagulant prescription and (2) a dietary vitamin K-guided strategy based on simple modifications of the amount of vitamin K-rich foods ingested per week. The primary efficacy end point was the percentage of patients who achieved a prespecified INR target at 90 days after randomization. Study population (n=132) predominantly included men with mechanical heart prostheses (58%) or atrial fibrillation (35%). Over time, patients allocated to the vitamin K-guided strategy reached the prespecified INR more frequently so that after 90 days of follow-up, 74% were on target compared with 58% of patients managed conventionally (P=0.04). Patients allocated to the dietary vitamin K-guided strategy had the same magnitude and direction of INR variation as those observed with the conventional approach in the short term (15 days) for both underanticaogulated and overanticoagulated patients. Minor bleeding or use of parenteral vitamin K were also marginally less frequent in patients managed according to the dietary intervention (1 [1.5%] versus 7 [11%]; P=0.06). CONCLUSIONS: A vitamin K-guided management strategy to adjust long-term oral anticoagulation is feasible and safe and may result in an increased chance of reaching target levels of INR.
- MeSH
- antikoagulancia aplikace a dávkování MeSH
- aplikace orální MeSH
- dieta MeSH
- dospělí MeSH
- financování organizované MeSH
- INR MeSH
- klinické křížové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- senioři MeSH
- vitamin K aplikace a dávkování MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
2nd ed. 9, 437 s. : il.
- MeSH
- klinické zkoušky jako téma MeSH
- randomizované kontrolované studie jako téma MeSH
- Publikační typ
- monografie MeSH
- Konspekt
- Farmacie. Farmakologie
- NLK Obory
- farmacie a farmakologie
In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease, with a worldwide trend toward early initiation. In this study, conducted at 32 centers in Australia and New Zealand, we examined whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease. METHODS: We randomly assigned patients 18 years of age or older with progressive chronic kidney disease and an estimated glomerular filtration rate (GFR) between 10.0 and 15.0 ml per minute per 1.73 m2 of body-surface area (calculated with the use of the Cockcroft-Gault equation) to planned initiation of dialysis when the estimated GFR was 10.0 to 14.0 ml per minute (early start) or when the estimated GFR was 5.0 to 7.0 ml per minute (late start). The primary outcome was death from any cause. RESULTS: Between July 2000 and November 2008, a total of 828 adults (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes) underwent randomization, with a median time to the initiation of dialysis of 1.80 months (95% confidence interval [CI], 1.60 to 2.23) in the early-start group and 7.40 months (95% CI, 6.23 to 8.27) in the late-start group. A total of 75.9% of the patients in the late-start group initiated dialysis when the estimated GFR was above the target of 7.0 ml per minute, owing to the development of symptoms. During a median follow-up period of 3.59 years, 152 of 404 patients in the early-start group (37.6%) and 155 of 424 in the late-start group (36.6%) died (hazard ratio with early initiation, 1.04; 95% CI, 0.83 to 1.30; P=0.75). There was no significant difference between the groups in the frequency of adverse events (cardiovascular events, infections, or complications of dialysis). CONCLUSIONS: In this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes. (Funded by the National Health and Medical Research Council of Australia and others; Australian New Zealand Clinical Trials Registry number, 12609000266268.)
- MeSH
- časové faktory MeSH
- chronické selhání ledvin komplikace mortalita terapie MeSH
- dialýza ledvin metody škodlivé účinky MeSH
- dospělí MeSH
- financování organizované MeSH
- hodnoty glomerulární filtrace MeSH
- infekce etiologie mortalita MeSH
- Kaplanův-Meierův odhad MeSH
- kardiovaskulární nemoci etiologie mortalita MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- proporcionální rizikové modely MeSH
- randomizované kontrolované studie jako téma MeSH
- uremie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- multicentrická studie MeSH
Polymyxin B fiber column is a medical device designed to reduce blood endotoxin levels in sepsis. Gram-negative-induced abdominal sepsis is likely associated with high circulating endotoxin. Reducing circulating endotoxin levels with polymyxin B hemoperfusion could potentially improve patient clinical outcomes. OBJECTIVE: To determine whether polymyxin B hemoperfusion added to conventional medical therapy improves clinical outcomes (mean arterial pressure [MAP], vasopressor requirement, oxygenation, organ dysfunction) and mortality compared with conventional therapy alone. DESIGN, SETTING, AND PATIENTS: A prospective, multicenter, randomized controlled trial (Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis [EUPHAS]) conducted at 10 Italian tertiary care intensive care units between December 2004 and December 2007. Sixty-four patients were enrolled with severe sepsis or septic shock who underwent emergency surgery for intra-abdominal infection. INTERVENTION: Patients were randomized to either conventional therapy (n=30) or conventional therapy plus 2 sessions of polymyxin B hemoperfusion (n=34). MAIN OUTCOME MEASURES: Primary outcome was change in MAP and vasopressor requirement, and secondary outcomes were PaO(2)/FIO(2) (fraction of inspired oxygen) ratio, change in organ dysfunction measured using Sequential Organ Failure Assessment (SOFA) scores, and 28-day mortality. RESULTS: MAP increased (76 to 84 mm Hg; P = .001) and vasopressor requirement decreased (inotropic score, 29.9 to 6.8; P < .001) at 72 hours in the polymyxin B group but not in the conventional therapy group (MAP, 74 to 77 mm Hg; P = .37; inotropic score, 28.6 to 22.4; P = .14). The PaO(2)/FIO(2) ratio increased slightly (235 to 264; P = .049) in the polymyxin B group but not in the conventional therapy group (217 to 228; P = .79). SOFA scores improved in the polymyxin B group but not in the conventional therapy group (change in SOFA, -3.4 vs -0.1; P < .001), and 28-day mortality was 32% (11/34 patients) in the polymyxin B group and 53% (16/30 patients) in the conventional therapy group (unadjusted hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.20-0.94; adjusted HR, 0.36; 95% CI, 0.16-0.80). CONCLUSION: In this preliminary study, polymyxin B hemoperfusion added to conventional therapy significantly improved hemodynamics and organ dysfunction and reduced 28-day mortality in a targeted population with severe sepsis and/or septic shock from intra-abdominal gram-negative infections. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00629382.
- MeSH
- antibakteriální látky terapeutické užití MeSH
- břicho MeSH
- financování organizované MeSH
- gramnegativní bakteriální infekce mortalita terapie MeSH
- hemodynamika MeSH
- hemoperfuze přístrojové vybavení MeSH
- lidé MeSH
- nemoci trávicího systému mortalita terapie MeSH
- polymyxin B terapeutické užití MeSH
- prospektivní studie MeSH
- randomizované kontrolované studie jako téma MeSH
- respirační transport MeSH
- septický šok mortalita patofyziologie terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- multicentrická studie MeSH
Controlled clinical trials, ISSN 0197-2456 vol. 24, no. 6S, December 2003
268-328 s. : il, tab. ; 26 cm
- MeSH
- digitalisové glykosidy MeSH
- digoxin terapeutické užití MeSH
- klinické zkoušky kontrolované jako téma MeSH
- management farmakoterapie MeSH
- medicína založená na důkazech MeSH
- randomizované kontrolované studie jako téma MeSH
- sběr dat MeSH
- srdeční selhání farmakoterapie MeSH
- Publikační typ
- sborníky MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- lékařství
- kardiologie
- farmacie a farmakologie
- MeSH
- biopsie metody škodlivé účinky MeSH
- desmopresin aplikace a dávkování MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- hemostatika aplikace a dávkování MeSH
- incidence MeSH
- injekce subkutánní MeSH
- krvácení epidemiologie etiologie prevence a kontrola MeSH
- ledviny patofyziologie patologie ultrasonografie MeSH
- lidé MeSH
- následné studie MeSH
- nemoci ledvin diagnóza patofyziologie MeSH
- randomizované kontrolované studie jako téma MeSH
- retrospektivní studie MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- klinické zkoušky, fáze IV MeSH
- srovnávací studie MeSH
OBJECTIVES: To assess the impact of rehabilitation in ICU on clinical outcomes. DATA SOURCES: Secondary data analysis of randomized controlled trials published between 1998 and October 2019 was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. STUDY SELECTION: We have selected trials investigating neuromuscular electrical stimulation or cycling exercises or protocolized physical rehabilitation as compared to standard of care in critically ill adults. DATA EXTRACTION: Mortality, length of stay in ICU and at hospital, days on mechanical ventilator, and adverse events. DATA SYNTHESIS: We found 43 randomized controlled trials (nine on cycling, 14 on neuromuscular electrical stimulation alone and 20 on protocolized physical rehabilitation) into which 3,548 patients were randomized and none of whom experienced an intervention-related serious adverse event. The exercise interventions had no influence on mortality (odds ratio 0.94 [0.79-1.12], n = 38 randomized controlled trials) but reduced duration of mechanical ventilation (mean difference, -1.7 d [-2.5 to -0.8 d], n = 32, length of stay in ICU (-1.2 d [-2.5 to 0.0 d], n = 32) but not at hospital (-1.6 [-4.3 to 1.2 d], n = 23). The effects on the length of mechanical ventilation and ICU stay were only significant for the protocolized physical rehabilitation subgroup and enhanced in patients with longer ICU stay and lower Acute Physiology and Chronic Health Evaluation II scores. There was no benefit of early start of the intervention. It is likely that the dose of rehabilitation delivered was much lower than dictated by the protocol in many randomized controlled trials and negative results may reflect the failure to implement the intervention. CONCLUSIONS: Rehabilitation interventions in critically ill patients do not influence mortality and are safe. Protocolized physical rehabilitation significantly shortens time spent on mechanical ventilation and in ICU, but this does not consistently translate into long-term functional benefit. Stable patients with lower Acute Physiology and Chronic Health Evaluation II at admission (<20) and prone to protracted ICU stay may benefit most from rehabilitation interventions.